The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.
TRC150094 is an Investigational Product for the treatment of CV risk associated with non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by increasing the energy expenditure and restoring mitochondrial flexibility which is deranged in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful benefits in well-established contributors of CV risk i.e., insulin resistance and hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP, over and above standard of care. The phase III trial is designed with an aim of determining the efficacy of TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks. Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary Objectives of the study are, 1. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension 2. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,250
Comitê de ética em Pesquisa do Hospital Pró Cardíaco
Rio de Janeiro, Botafogo, Brazil
RECRUITINGAvenida Angélica
São Paulo, CEP, Brazil
RECRUITINGRua Silva Jardim
São Bernardo do Campo, São Paulo, Brazil
RECRUITINGAv. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS
Canoas, Brazil
RECRUITINGRua Coronel Aureliano de Camargo,905, Centro,
Tatuí, Brazil
RECRUITINGBAPS Pramukh Swami Hospital,
Surat, Gujarat, India
RECRUITINGBangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,
Bangalore, Karnataka, India
RECRUITINGGovernment Medical College, Government Medical College Campus,
Calicut, Kerala, India
RECRUITINGLisie Hospital
Kochi, Kerala, India
RECRUITINGIndian Institute of Diabetes
Thiruvananthapuram, Kerala, India
RECRUITING...and 11 more locations
Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c
Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms
Time frame: 24 Weeks
Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score
Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms
Time frame: 24 Weeks
Change in MAP
Mean change in MAP from baseline to 24 weeks of treatment
Time frame: 24 Weeks
Change in non-HDL cholesterol
Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment
Time frame: 24 Weeks
Change in HbA1c
Mean change in HbA1c from baseline to 24 weeks of treatment
Time frame: 24 Weeks
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